Trials最新文献

{"title":"Developing a knowledge transfer and exchange strategy for a clinical trials unit.","authors":"Annabelle South, Berta Terré Torras, Hannah Rush, Anna Goodman, Sharon Love","doi":"10.1186/s13063-024-08681-x","DOIUrl":"10.1186/s13063-024-08681-x","url":null,"abstract":"<p><strong>Need for a strategic approach to knowledge transfer and exchange: </strong>Late-phase clinical trials and systematic reviews find results that have the potential to improve health outcomes for people. However, there are often delays in these results influencing clinical practice. We developed a knowledge transfer and exchange strategy to support research teams, aiming to identify activities along the research process to maximise and accelerate the research impact.</p><p><strong>Our knowledge transfer and exchange strategy: </strong>The strategy has five strands of activity across the life-course of our research: 1. Partnerships with external stakeholders (including patient and public involvement, charities, policymakers, healthcare professionals, professional bodies, regulators and industry) 2. Communication (including the development of research impact strategies and use of communication tools and channels) 3. Maximising the scientific value of our studies (including open access, data and sample sharing, and incorporating multi-disciplinary components within studies) 4. Strengthening capacity (including building internal and partner capacity to communicate effectively, and strengthening the capacity of external stakeholders to understand and apply our research). 5. Learning and sharing (evaluating the impact of research, sharing lessons learnt internally and externally) The strategy has helped trial teams think systematically about impact and was easy to use.</p><p><strong>Conclusions: </strong>Our strategy helps researchers systematically identify activities which may improve the usefulness and uptake of their study results. While developed in a single trials unit, we think it may be of use to others.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"3"},"PeriodicalIF":2.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials {1}.","authors":"Inês A Trindade, Andreia Soares, David Skvarc, Diogo Carreiras, Joana Pereira, Óscar Lourenço, Filipa Sampaio, Bruno de Sousa, Teresa C Martins, Paula Boaventura, Joana Marta-Simões, Helena Moreira","doi":"10.1186/s13063-024-08626-4","DOIUrl":"10.1186/s13063-024-08626-4","url":null,"abstract":"<p><strong>Background: </strong>Breast cancer is the most diagnosed cancer in women worldwide and carries a considerable psychosocial burden. Interventions based on Acceptance and Commitment Therapy (ACT) and compassion-based approaches show promise in improving adjustment and quality of life in people with cancer. The Mind programme is an integrative ACT and compassion-based intervention tailored for women with breast cancer, which aims to prepare women for survivorship by promoting psychological flexibility and self-compassion. A pilot study of the Mind programme has shown acceptability and preliminary efficacy in improving quality of life and psychological health. This paper presents the study protocol of two randomised controlled trials that aim to test the efficacy and cost-effectiveness of an optimised version of the Mind programme in women with breast cancer.</p><p><strong>Methods: </strong>Participants will be women diagnosed with breast cancer randomly assigned to the Mind programme or a support group intervention (active control) in a 1:1 ratio for study 1, while study 2 includes one more arm (treatment as usual; inactive control) and a 2:2:1 ratio. Both interventions will be delivered weekly via an 8-session face-to-face or online group format. Data will be collected at baseline, post-treatment and 6-month follow-up. The efficacy and cost-effectiveness of the two interventions will be assessed. Treatment outcomes will comprise cancer-specific quality of life (primary outcome), anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related quality of life, resource use, and intervention's acceptability and feasibility. Study 1 will also include immunological and epigenetic markers associated with breast cancer prognosis and mental health. Outcome assessors will be blind to group allocation. Statistical analyses will be conducted using an intention-to-treat approach. Analyses of moderators and mediators of change will also be performed.</p><p><strong>Discussion: </strong>These trials examine the efficacy and cost-effectiveness of an integrative ACT and compassion-based intervention tailored for women with breast cancer. Greater improvements in psychosocial, biological and resource use are expected in the Mind group, when compared to the control group(s). Results will likely support the potential benefits of the Mind programme for breast cancer patients and highlight the clinical relevance of integrative and holistic interventions in oncology. TRIALS REGISTRATION {2A, 2B}: ClinicalTrials.gov NCT05642897 and NCT06212414. Registered on December 8, 2022, and January 18, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"5"},"PeriodicalIF":2.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modulating delirium through stimulation (MoDeSt): study protocol for a randomized, double-blind, sham-controlled trial assessing the effect of postoperative transcranial electrical stimulation on delirium incidence.","authors":"Sophie Leroy, Viktor Bublitz, Ulrike Grittner, Robert Fleischmann, Falk von Dincklage, Daria Antonenko","doi":"10.1186/s13063-024-08699-1","DOIUrl":"10.1186/s13063-024-08699-1","url":null,"abstract":"<p><strong>Background: </strong>Postoperative delirium (POD) is the most common neurological adverse event among elderly patients undergoing surgery. POD is associated with an increased risk for postoperative complications, long-term cognitive decline, an increase in morbidity and mortality as well as extended hospital stays. Delirium prevention and treatment options are currently limited. This study will evaluate the effect of transcranial electrical stimulation (tES) on the incidence of POD.</p><p><strong>Methods: </strong>We will perform a randomized, double-blind, sham-controlled trial using single-session postoperative application of tES in the recovery room in 225 patients (> 65 years) undergoing elective major surgery. Patients will be randomly allocated (ratio 1:1:1) to one of three study groups: (1) alpha-tACS over posterior parietal cortex [2 mA, 20 min], (2) anodal tDCS over left dorsolateral prefrontal cortex [2 mA, 20 min], (3) sham [2 mA, 30 s]. Delirium will be screened twice daily with the 3-min diagnostic interview Confusion Assessment Method (3D-CAM) in the 5 days following surgery. The primary outcome is the incidence of POD defined as at least one positive screening during the five first postoperative days compared between tACS and sham groups. Secondary outcomes include delirium severity, duration, phenotype, postoperative pain, postoperative nausea and vomiting, electroencephalographic (EEG) markers, and fluid biomarkers.</p><p><strong>Discussion: </strong>If effective, tES is a novel, easily applicable, non-invasive method to prevent the occurrence of POD. The comprehensive neurophysiological and biofluid assessments for markers of (neuro-)inflammation and neurodegeneration will shed light on the pathomechanisms behind POD and further elucidate the (after-)effects of tES. The potential implications for the postoperative recovery comprise enhanced patient safety, neurocognitive outcome, perioperative manageability but also reduced healthcare costs.</p><p><strong>Trial registration: </strong>German Clinical Trial Registry DRKS00033703. Registered on February 23, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"4"},"PeriodicalIF":2.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimating relative risks and risk differences in randomised controlled trials: a systematic review of current practice.","authors":"Jacqueline Thompson, Samuel I Watson, Lee Middleton, Karla Hemming","doi":"10.1186/s13063-024-08690-w","DOIUrl":"10.1186/s13063-024-08690-w","url":null,"abstract":"<p><strong>Background: </strong>Guidelines for randomised controlled trials (RCTs) recommend reporting relative and absolute measures of effect for binary outcomes while adjusting for covariates. There are a number of different ways covariate-adjusted relative risks and risk differences can be estimated.</p><p><strong>Objectives: </strong>Our goal was to identify methods used to estimate covariate-adjusted relative risk and risk differences in RCTs published in high-impact journals with binary outcomes. Other secondary objectives included the identification of how covariates are chosen for adjustment and whether covariate adjustment results in an increase in statistical precision in practice.</p><p><strong>Methods: </strong>We included two-arm parallel RCTs published in JAMA, NEJM, Lancet, or the BMJ between January 1, 2018, and March 11, 2023, reporting relative risks or risk differences as a summary measure for a binary primary outcome. The search was conducted in Ovid-MEDLINE.</p><p><strong>Results: </strong>Of the 308 RCTs identified, around half (49%; 95% CI: 43-54%) reported a covariate-adjusted relative risk or risk difference. Of these, 82 reported an adjusted relative risk. When the reporting was clear (n = 65, 79%), the log-binomial model (used in 65% of studies; 95% CI: 52-76%) and modified Poisson (29%; 95% CI: 19-42%) were most commonly used. Of the 92 studies that reported an adjusted risk difference, when the reporting was clear (n = 56, 61%), the binomial model (used in 48% of studies; 95% CI: 35-62%) and marginal standardisation (21%; 95% CI: 12-35%) were the common approaches used.</p><p><strong>Conclusions: </strong>Approximately half of the RCTs report either a covariate-adjusted relative risk or risk difference. Many RCTs lack adequate details on the methods used to estimate covariate-adjusted effects. Of those that do report the approaches used, the binomial model, modified Poisson and to a lesser extent marginal standardisation are the approaches used.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"1"},"PeriodicalIF":2.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11694472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Benzodiazepine agonist treatment for patients with benzodiazepine dependence undergoing opioid agonist treatment: a study protocol for the randomized controlled trial BMX-BAR.","authors":"Fatemeh Chalabianloo, Lars Thore Fadnes, Jörg Assmus, Jon Mordal, Kristin K Solli, Kjetil S Dale, Christina D Andersen, Silvia Zavenova, Beathe H Rønning, Andreas W Blomkvist, Martin Ryssdal, Wasifa S J Butt, Anne Marciuch, Anne G Ørmen, Christian Ohldieck, Else-Marie Løberg, Kjell Arne Johansson","doi":"10.1186/s13063-024-08692-8","DOIUrl":"10.1186/s13063-024-08692-8","url":null,"abstract":"<p><strong>Background: </strong>There is a lack of knowledge on effective treatment methods for comorbid benzodiazepine dependence in populations undergoing opioid agonist treatment (OAT). Tapering and discontinuation of benzodiazepines has long been considered the standard treatment, even though there is limited evidence for this practice. There is also limited research on benzodiazepine agonist treatment; however, peer and clinical experiences indicate that such approaches may be beneficial for a subgroup of the patients with long-lasting benzodiazepine dependence not responding to other treatment approaches. A randomized controlled trial will be conducted to compare the efficacy and safety of stabilizing agonist treatment using prescribed benzodiazepines with standard treatment in reducing illicit benzodiazepine use.</p><p><strong>Methods: </strong>The target sample is 108 participants at outpatient OAT clinics in six Norwegian cities/counties (Bergen/Vestland, Tønsberg/Vestfold, Skien/Telemark, Fredrikstad/Østfold, Tromsø/Troms, and Lillestrøm/Akershus). The main inclusion criteria are benzodiazepine dependence of ≥ 5 years, using ≥ 5 days a week during the last month, and previous attempts at tapering. Participants will be randomly assigned to receive either a 26-week benzodiazepine stabilizing treatment (15-30 mg diazepam or 50-100 mg oxazepam daily), or a 20-week tapering using the same medications and equivalent initial dosages. All participants will be given access to consultations from OAT therapists with psychosocial follow-up in accordance with current clinical practice. The primary outcome is the use of illicit benzodiazepines assessed by observed urinary tests at week 24. Secondary outcomes include mental health symptoms, quality of life, cognitive performance, violence risk, other substance use, treatment retention, and life satisfaction. Additionally, the study will assess treatment-related adverse events as well as the cost-effectiveness of the intervention.</p><p><strong>Discussion: </strong>This is the first randomized controlled trial of benzodiazepine agonist treatment for benzodiazepine dependence. The research project will assess efficacy and safety of stabilizing treatment with prescribed benzodiazepines compared to benzodiazepine tapering and discontinuation regarding use of illicit benzodiazepines and accordingly well-being of patients with concurrent benzodiazepine and opioid dependence undergoing OAT. If the intervention is found to be efficacious and safe, it will be considered one of the options to standard treatment for this patient group.</p><p><strong>Trial registration: </strong>EU trial number: EudraCT: 2021-004981-37. Registered on December 13, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"2"},"PeriodicalIF":2.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11694363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health checks for autistic adults: study protocol for a cluster randomised controlled trial.","authors":"Jeremy R Parr, Helen Taylor, Colin Wilson, Clare Scarlett, Sarah Al-Asmori, Carole Buckley, Sally-Ann Cooper, Cristina Fernandez-Garcia, Tracy Finch, Rhianna Lees, Nicholas Lennox, Hannah Merrick, Sebastian Moss, Christina Nicolaidis, Malcolm Osbourne, Dora M Raymaker, Tomos Robinson, Anna Urbanowicz, James M S Wason, Barry Ingham","doi":"10.1186/s13063-024-08641-5","DOIUrl":"10.1186/s13063-024-08641-5","url":null,"abstract":"<p><strong>Background: </strong>Autistic people commonly have physical and mental health conditions. They also frequently experience barriers to accessing healthcare, contributing to problems identifying and treating health conditions. These factors may lead to increased and earlier morbidity and lower average life expectancy for autistic people. Health checks specifically designed for autistic people, incorporating adjustments to healthcare, may help to overcome these barriers and reduce health inequalities. This trial aims to investigate the clinical and cost-effectiveness of a primary care health check for autistic adults and explore factors related to implementation such as acceptability and feasibility of delivery. The trial is co-designed and delivered by health professionals, autistic people, carers and supporters, and researchers.</p><p><strong>Methods: </strong>This is a clinical and cost-effectiveness, cluster randomised controlled trial of a primary care health check for autistic adults. Primary care practices will be randomised into one of two groups (intervention or control). Two hundred autistic adults (aged 18 years and over) who provide baseline data will be recruited via participating practices. Data will be collected through quantitative and qualitative methods. The primary outcome will be the incidence of new health needs/conditions detected and met at 9 months (data gathered from participant's GP records). Secondary outcomes will include the following: cost-effectiveness, measured as incremental cost per quality-adjusted life year gained over 9 months; the extent of health monitoring and health promotion needs met at 9 months; the incidence of social care needs identified at 9 months; changes in participant or carer general health; changes in quality of life; primary and secondary health and social care resource usage and costs. A qualitative study will explore views about the acceptability of the health check, its utility and future use.</p><p><strong>Discussion: </strong>This study will examine the effectiveness and cost-effectiveness of a primary care health check for autistic adults in identifying new health conditions and needs. If the intervention is effective, it would provide strong evidence for implementation into routine healthcare, therefore enabling earlier health condition diagnosis and opportunities for treatment, reducing the health inequalities experienced by autistic people.</p><p><strong>Trial registration: </strong>ISRCTN, retrospectively registered on 20 July 2023. https://www.isrctn.com/ISRCTN30156776 (ISRCTN registration number: 30156776).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"858"},"PeriodicalIF":2.0,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11686900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142910912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia.","authors":"I Gardoki-Souto, O Martín de la Torre, B Hogg, D Redolar-Ripoll, L Martínez Sadurní, M Fontana-McNally, J M Blanch, W Lupo, V Pérez, J Radua, B L Amann, A Valiente-Gómez, A Moreno-Alcázar","doi":"10.1186/s13063-024-08708-3","DOIUrl":"10.1186/s13063-024-08708-3","url":null,"abstract":"<p><strong>Background: </strong>Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as Eye Movement Desensitization and Reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients, and if its potential is boosted with the addition of MtCS.</p><p><strong>Methods: </strong>Ninety-six patients with FM and a history of traumatic events will be randomly allocated to the treatment as usual (TAU) condition, EMDR + active-MtCS condition, or EMDR + sham-MtCS condition. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, wellbeing, self-care, emotional regulation, self-esteem, and cognitive functioning.</p><p><strong>Discussion: </strong>This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS.</p><p><strong>Trial registration number: </strong>This trial was registered at ClinicalTrials.gov on 2 August 2019, identifier: NCT04084795.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"856"},"PeriodicalIF":2.0,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11686963/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142910913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Evaluating a multicomponent intervention for managing kidney outcomes among patients with moderate or advanced chronic kidney disease (CKD): protocol for the Strategies for Kidney Outcomes Prevention and Evaluation (SKOPE) randomized controlled trial.","authors":"Tazeen Hasan Jafar, Ngiap Chuan Tan, Mihir Gandhi, Sungwon Yoon, Eric Finkelstein, Peter Moey Kirm Seng, Ruiheng Ong, Anandan Gerard Thiagarajah, Bing Long Lee, Ka Chi To, Aminath Shiwaza Moosa","doi":"10.1186/s13063-024-08698-2","DOIUrl":"10.1186/s13063-024-08698-2","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"857"},"PeriodicalIF":2.0,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11686998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142910911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial.","authors":"Karen J Bosma, Myriam Lafreniere-Roula, Arlene Jiang, Anna Heath, Yongdong Ouyang, Kaitlyn Wade, Pingzhao Hu, Karen E A Burns, Claudio M Martin, Yoanna Skrobik, Sorcha Mulligan, Kevin E Thorpe, Laurent Brochard","doi":"10.1186/s13063-024-08669-7","DOIUrl":"10.1186/s13063-024-08669-7","url":null,"abstract":"<p><strong>Background: </strong>We previously published the protocol and statistical analysis plan for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study in Trials ( https://doi.org/10.1186/s13063-023-07163-w ). This update summarizes changes made to the statistical analysis plan for the trial since the publication of the original protocol and statistical analysis plan.</p><p><strong>Methods/design: </strong>The Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (PROMIZING) study is a multi-center, open-label, randomized controlled trial designed to determine if ventilation with proportional assist ventilation with load-adjustable gain factors will result in a shorter duration of time spent on mechanical ventilation compared to ventilation with pressure support ventilation for patients with acute respiratory failure. The statistical analysis plan for the trial was incorporated into the original publication of the protocol in Trials ( https://doi.org/10.1186/s13063-023-07163-w ) and was based on version 5.0 of the study protocol and version 1.0 of the statistical analysis plan (SAP), which included plans for both frequentist and Bayesian analyses. We have since updated the SAP to refine the Bayesian analysis plan, update the multistate model diagram, and include plans for a cluster analysis to determine if there is heterogeneity of treatment effect. This update summarizes the changes made and their rationale and provides a refined SAP for the PROMIZING trial with additional background information, in adherence with guidelines for the prospective reporting of SAPs for randomized controlled trials.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02447692 prospectively registered May 19, 2015.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"855"},"PeriodicalIF":2.0,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142907266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of different puncture needles used for endoscopic ultrasound-guided fine-needle biopsy of Gastrointestinal subepithelial lesions (≤ 2 cm) with respect to the adequacy of specimen collection: study protocol for a multicenter randomized prospective trial.","authors":"Yasunobu Yamashita, Reiko Ashida, Toshio Shimokawa, Tetsuya Ikeda, Osama Inatomi, Takashi Ogura, Yuzo Kodama, Kotaro Takeshita, Mamoru Takenaka, Akiko Tsujimoto, Yoshiki Nakai, Yukihisa Fujinaga, Masayuki Kitano","doi":"10.1186/s13063-024-08654-0","DOIUrl":"10.1186/s13063-024-08654-0","url":null,"abstract":"<p><strong>Background: </strong>Gastrointestinal subepithelial lesions (SELs) range from benign to malignant. Endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) is used widely for pathological diagnosis of SELs. Early diagnosis and treatment are important because all Gastrointestinal stromal tumors (GISTs) have some degree of malignant potential. Diagnosing SELs with EUS-FNB is more difficult than diagnosing other tumors because an accurate diagnosis of GIST requires a sufficient tissue sample for immunostaining, which is part of the diagnostic protocol. Moreover, EUS-FNB is less accurate for diagnosis based on samples from SELs measuring ≤ 2 cm. However, our retrospective study showed that more than 50% of patients with SELs ≤ 2 cm were diagnosed as GIST. Therefore, EUS-FNB needles are required with adequate sampling in SELs measuring ≤ 2 cm. Previously, we conducted a retrospective single-center study of SELs measuring ≤ 2 cm, and reported that EUS-FNB with a Fork-tip needle was superior to that with a Franseen needle in that the former acquires sufficient sample. This multicenter comparative open-label superiority study is designed to verify whether a 22G Fork-tip needle is superior to a 22G Franseen needle with respect to sample acquisition.</p><p><strong>Methods/design: </strong>Present study will randomly assign for 110 patients (55 in the Fork-tip needle group and 55 in the Franseen needle group) with SELs measuring ≤ 2 cm, all of whom are managed at one of the 10 participating endoscopic centers. The primary endpoint evaluates the superiority of a 22G Fork-tip needle over a 22G Franseen needle for collection of an adequate tissue specimen at the first puncture. The secondary endpoints compare successful puncture rate, procedure completion rate, number of adverse events, diagnostic suitability of the first puncture specimen for GIST, and the number of punctures required until adequate specimen collection.</p><p><strong>Discussion: </strong>The outcomes may provide insight into the optimal needle choice for diagnosis of SELs ≤ 2 cm, thereby aiding development of practice guidelines. Present study is expected to promote early definitive diagnosis of GISTs, thereby increasing the number of cases that can receive curative treatment and improving prognosis.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials (JRCT; trial registration: jRCTs052230144). Registered December 13, 2023. (URL; https://jrct.niph.go.jp/re/reports/detail/76858 ).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"852"},"PeriodicalIF":2.0,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11681732/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142898221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}